TABLE 2.
Pharmacokinetic parameters of GST-HG171 and ritonavir in GST-HG171/ritonavir monotherapy and co-administration with itraconazolea
| Therapy | PK parameter (unit) | GST-HG171/ritonavir (N = 12) | Itraconazole + GST-HG171/ritonavir (N = 12) |
|---|---|---|---|
| GST-HG171 | Cmax (ng/mL) | 5,748.80 ± 1,066.62 (18.55) | 6,223.81 ± 1,196.93 (19.23) |
| AUC0-t (ng·h/mL) | 45,120.83 ± 11,319.05 (25.09) | 6,6411.14 ± 20,625.66 (31.06) | |
| AUC0-∞ (ng·h/mL) | 45,559.24 ± 11,607.99 (25.48) | 6,6702.59 ± 20,609.36 (30.90) | |
| t1/2 (h) | 4.71 ± 1.22 (25.85) | 6.20 ± 1.25 (20.13) | |
| Tmax (h) | 1.75 (0.7506, 3.0011) | 1.25 (0.5003, 3.0011) | |
| CL/F (mL/h) | 3,504.68 ± 943.19 (26.91) | 2,459.79 ± 796.90 (32.40) | |
| Vz/F (mL) | 2,3149.93 ± 6,614.00 (28.57) | 21,077.31 ± 4,555.97 (21.62) | |
| Ritonavir | Cmax (ng/mL) | 1,439.58 ± 684.74 (47.57) | 1,883.72 ± 900.94 (47.83) |
| AUC0-t (ng·h/mL) | 8,280.67 ± 3,509.34 (42.38) | 11,397.95 ± 5,747.06 (50.42) | |
| AUC0-∞ (ng·h/mL) | 8,449.27 ± 3,574.10 (42.30) | 11,617.58 ± 5,755.22 (49.54) | |
| t1/2 (h) | 4.15 ± 0.34 (8.21) | 4.80 ± 1.15 (23.98) | |
| Tmax (h) | 2.50 (2.0008, 3.0011) | 2.00 (1.5003, 3.0011) | |
| CL/F (mL/h) | 13,521.57 ± 4,567.98 (33.78) | 10,424.98 ± 4,313.15 (41.37) | |
| Vz/F (mL) | 81,576.99 ± 29,946.58 (36.71) | 68,339.48 ± 22,923.68 (33.54) |
a
All parameters except Tmax are presented as mean ± SD (CV%). Tmax is expressed as the median (minimum, maximum).